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Oncology / Rescue Agent

Calcium Folinate API Supplier

CAS 1492-18-8  ·  Oncology / Rescue Agent · Leucovorin · Folate Antagonist Rescue

GMP-certified Calcium Folinate (Leucovorin Calcium) API — essential oncology rescue agent and 5-FU modulator. USDMF and CEP both on file. Complete regulatory dossier with every inquiry.

Request Complete Source Quote View Specifications
Purity≥98.0%HPLC
MOQ10 kgCommercial supply
RegulatoryUSDMFBoth on file
Response24 hrFull dossier
OriginMultiIndia / China
Technical Specifications

Calcium Folinate API — Full Technical Profile

INN / Generic NameCalcium Folinate
CAS Number1492-18-8
Molecular FormulaC₂₀H₂₁CaN₇O₇
Molecular Weight511.5 g/mol (calcium salt)
Mechanism / ClassFolinic acid / reduced folate — rescues folate antagonist toxicity; potentiates 5-FU
Therapeutic UseColorectal cancer (5-FU modulation), methotrexate rescue, megaloblastic anaemia
Purity (HPLC)≥98.0%
AppearanceYellow to orange-yellow crystalline powder
StorageStore below 25°C; protect from light
MOQ (commercial)10 kg
MOQ (R&D)100 g – 1 kg
Lead Time4–7 weeks
Regulatory FilingsUSDMF + CEP
Country of OriginIndia / China
Regulatory Documentation

Complete Source Quote — What's Included

Every Calcium Folinate API inquiry returns a complete regulatory package in 24 hours.

📋
Certificate of Analysis
Full CoA — assay ≥98.0%, enantiomeric purity (L-form), related substances, water content.
✓ Included
🇺🇸
USDMF on File
US Drug Master File active. Reference letter available for FDA oncology submissions.
✓ On File
🇪🇺
CEP Certified
Certificate of Suitability (Ph.Eur.) issued. Supports EMA marketing authorisation.
✓ CEP Issued
🧪
Chiral Purity
Enantiomeric purity of L-form confirmed by chiral HPLC — critical for pharmacological activity.
✓ Included
📊
Stability Data
ICH Q1A stability data — photosensitivity studies included given light-sensitivity profile.
✓ Included
🏭
GMP Certificate
Current GMP certificate from manufacturing site.
✓ Included
Market Context

Calcium Folinate — Key Figures

$800M+
Global Leucovorin market
L-form
Enantiomeric purity confirmed
10 kg
Commercial MOQ
FOLFOX
Key oncology regimen component
Complete Source Quote

Get Your Calcium Folinate API Quote

Submit your requirements. We'll respond with a complete package within 24 business hours.

  • Certificate of Analysis (CoA)
  • USDMF + CEP — reference letter / status
  • Full impurity profile per ICH Q3A
  • Stability data summary
  • GMP certificate + site details
  • Pricing, MOQ, and lead time
  • Country of origin confirmation
Calcium Folinate API Inquiry
Complete Source Quote · 24-hour response
PDF · DOC · XLS · Max 10 MB

✓ 24-hour response  ·  [email protected]

Common Questions

Calcium Folinate API — FAQ

What is the difference between Leucovorin and Calcium Folinate?
Leucovorin and Calcium Folinate are synonymous names for the same compound — the calcium salt of folinic acid (5-formyl-tetrahydrofolic acid). Calcium Folinate is the INN used in European and international pharmacopoeias.
Is enantiomeric purity documented for Calcium Folinate?
Yes — L-form (active) enantiomeric purity is confirmed by chiral HPLC as part of the standard CoA. This is critical because only the L-isomer is pharmacologically active. The specification and result are included in every inquiry response.
Is Calcium Folinate supplied in both injectable and oral grades?
We supply pharmaceutical-grade Calcium Folinate suitable for both parenteral (injectable) and oral solid dosage forms. Injectable-grade includes additional testing for particulates, endotoxins, and sterility indicators.
Does Generic Specialty Group manufacture Calcium Folinate?
No — Generic Specialty Group is an independent API sourcing partner, not a manufacturer. We source from a curated network of GMP-audited manufacturers globally, giving you access to multiple qualified sources and competitive pricing without being tied to a single facility.
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